Procurement Summary
Country : Netherlands
Summary : Quality, Safety and Efficacy of Medicines
Deadline : 07 Nov 2024
Other Information
Notice Type : Tender
TOT Ref.No.: 107562986
Document Ref. No. : 568568-2024
Financier : European Medicines Agency (EMA)
Purchaser Ownership : Public
Tender Value : EUR 33000000
Purchaser's Detail
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Login to see detailsTender Details
The European Medicines Agency (EMA) has framework contracts in place with multiple contractors to perform quality, safety and efficacy studies to generate evidence to support regulatory decision-making for human and veterinary medicines. As these framework contracts will expire in the last quarter of 2025, the Agency is preparing the launch of a new procurement procedure that will be open to economic operators established in the European Union (EU) and the European Economic Area (EEA), with the aim to sign the new framework contracts in the last quarter of 2025. Given the different scientific areas in which EMA requires research, the new procurement procedure will be structured into different lots. While the exact information on the structure and scope of each of the lots will be made available only at the time of launch of the new procurement procedure, the following scientific research areas are envisaged to be covered under the new procurement procedure: (a) translational research aimed at ensuring (non)clinical scientific study results translate into applicable measures that benefit patient health; (b) research to evaluate medicine use in pregnancy and breastfeeding and benefits and risks associated with that use; (c) research to support regulatory decision-making in the area of veterinary medicinal products (VMPs), and associated benefits and risks to public health, animal health, or the environment; (d) methodological and statistical research; (e) qualitative research...
Document Type: Prior Information Notice
Reference Number: EMA/2024/OP/0016-PIN
Contract Type: services
Estimated Value: 33000000 - EUR
Authority Type: eu-ins-bod-ag
Doc Title: Quality, safety and efficacy of medicines
Dispatch Date: 2024-09-20
Publish Date: 2024-09-23
Submission Date: 2024-11-07
Documents
Tender Notice